Hologic, Inc. · 3 days ago
Quality Supply Assurance Specialist II
San Diego, CA
Full-time
Onsite
Entry, Mid Level
$66K/yr - $103K/yr
2+ years expHologic, Inc. is seeking a Quality Supply Assurance Specialist II to support their business operations by ensuring timely resolution of quality issues while maintaining compliance for non-conformances and associated quality records. The role involves working cross-functionally to support MRB and product quality forums, guiding investigations, and contributing to continuous improvement across the Quality Management System.
BiotechnologyHealth CareHealth DiagnosticsWomen's
Responsibilities
Ensure timely resolution of quality issues while maintaining full compliance for non-conformances and associated quality records
Work cross-functionally to support MRB and product quality forums
Guide investigations and contribute to continuous improvement across our Quality Management System
Qualification
Required
Working knowledge of FDA Quality System Regulations and ISO 13485
Familiarity with risk management concepts and quality workflows related to non-conformances, corrections, and corrective actions
Understanding of Quality Systems elements such as Material Review Board (MRB), Product Quality Committee (PQC), and quality metrics
Knowledge of ERP-based quality transactions and basic quality data reporting
Ability to review and assess non-conformance, correction, and corrective action records for accuracy, completeness, and appropriateness
Strong facilitation skills to support and coordinate cross-functional meetings (MRB, PQC, Product Response Team)
Proficiency in Microsoft Word, Excel (including graphing and data presentation), and related office tools
Excellent oral and written communication skills, including clear technical writing for quality records and SOP support
Ability to support investigations using quality workflows, trend queries, and other analytical tools
Strong organizational and multitasking skills in a detail-oriented, regulated environment
Self-starter who works effectively with minimal supervision
Detail-focused and diligent in maintaining compliant, accurate quality records
Collaborative team member who enjoys partnering across departments and acting as a QA interface
Continuous improvement mindset, actively contributing ideas to improve processes and quality system performance
Accountable and reliable, ensuring timeliness in deliverables and follow-through on quality commitments
BA/BS Degree Required, Or Equivalent Experience/certification
2+ years of experience in Quality, with strong emphasis on Quality Systems and non-conformances
Experience in an FDA-regulated environment is required
Experience supporting external audits and regulatory body inspections is beneficial
Preferred
Experience working in ERP systems (strongly preferred)
ASQ Certification (CQA, CQE) preferred
Benefits
Comprehensive training
Continued development and training
Company
Hologic, Inc.
We’re an innovative medical technology company whose purpose is to enable healthier lives everywhere, every day.
5001-10000 employees
H1B Sponsorship
Hologic, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (31)
2024 (20)
2023 (15)
2022 (32)
2021 (20)
2020 (14)
Funding
Current Stage
Public CompanyTotal Funding
$2.87B2025-10-21Private Equity
2025-10-21Acquired
2025-07-15Post Ipo Debt· $2.42B
Leadership Team
Stephen MacMillan
Chairman President & CEO
Karen Harrington
Director Scientific Affairs
Recent News
Company data provided by crunchbase